FDA UDI In Commercial Distribution 🇺🇸 United States

Teladoc Health, Inc

DI: 00853553005646 · Model: Welcome Kit, 4G Cellular Body Scale WM1500 · LIVONGO HEALTH, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Teladoc Health, Inc
Primary DI
00853553005646
Version / Model
Welcome Kit, 4G Cellular Body Scale WM1500
Catalog Number
KIT06307
Company Name
LIVONGO HEALTH, INC
Labeler DUNS
829984561
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-25
Public Version
1
Public Version Date
2023-09-04
Public Version Status
New
Public Device Record Key
c312b455-407f-472f-8f3b-85bbdc6f8839

Device Description

KIT, WELCOME, 4G CELLULAR BODY SCALE WM1500 1 Scale, 1 Scale User Guide, 4 AA Alkaline Batteries

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FRI Scale, Stand-On, Patient

GMDN Terms

Code Name
38211 Stand-on floor scale, electronic

Identifiers

Type ID
Primary 00853553005646

Customer Contacts

Phone
800.945.4355

Storage Conditions

Type
Handling Environment Atmospheric Pressure
Temperature Range
80 – 105 KiloPascal
Type
Handling Environment Humidity
Temperature Range
15 – 90 Percent (%) Relative Humidity
Type
Handling Environment Temperature
Temperature Range
10 – 40 Degrees Celsius
Type
Storage Environment Atmospheric Pressure
Temperature Range
80 – 105 KiloPascal
Type
Storage Environment Humidity
Temperature Range
– 90 Percent (%) Relative Humidity
Type
Storage Environment Temperature
Temperature Range
-20 – 55 Degrees Celsius